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AIMT

Aimmune

$22.06

2.26 (11.41%)

, DBVT

DBV Technologies

$9.72

0.75 (8.36%)

08:28
09/11/19
09/11
08:28
09/11/19
08:28

FDA posts briefing docs for Aimmune panel, brings up allergic reactions

The FDA posted breifing documents ahead of Friday's panel meeting for Aimmune Therapeutics' (AIMT) peanut allergy treatment Palforzia. The FDA states, "Palforzia treated subjects in the pediatric safety population reported an increased number of allergic reactions, including systemic allergic reactions, compared to placebo-treated subjects. A total of 9.4% subjects taking Palforzia had a systemic allergic reaction during initial dose escalation and updosing compared to 3.8% of placebo subjects. This imbalance was seen during maintenance as well with 8.7% of Palforzia treated patients having a systemic allergic reaction compared to 1.7% of placebo-treated subjects. During the maintenance period, 7.7% of Palforzia treated subjects used epinephrine compared to 3.4% in the placebo group. Twelve subjects treated with Palforzia were diagnosed with eosinophilic esophagitis (EoE) in the entire clinical development program while no subjects in the placebo group of the controlled safety population received a diagnosis of EoE. Similar safety data are seen in the adult population with respect to systemic allergic reactions." DBV Technologies (DBVT) is also developing a treatment for peanut allergy. Shares of Aimmune, after rallying 12% yesterday, are down 3% to $21.43 in premarket trading. Reference Link

AIMT

Aimmune

$22.06

2.26 (11.41%)

DBVT

DBV Technologies

$9.72

0.75 (8.36%)

  • 13

    Sep

AIMT Aimmune
$22.06

2.26 (11.41%)

08/05/19
PIPR
08/05/19
NO CHANGE
Target $60
PIPR
Overweight
Aimmune FDA panel could break downward share trend, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Aimmune Therapeutics with a $60 price target after traveling with management. Despite the recent share performance, new money investment in this name, "even in the teeth of the current trend," may make sense, Raymond tells investors in a research note. The analyst thinks the company's September 13 FDA panel meeting for AR101 in peanut allergy "could serve as the catalyst to break the stock's downward trend." Further, Raymond feels "increasingly confident" in a "strong" commercial launch for AR101. Investors "who can look past the scary technicals can be rewarded here," he says.
08/05/19
HCWC
08/05/19
NO CHANGE
Target $25
HCWC
Buy
H.C. Wainwright reiterates Buy on DBV ahead of expected BLA resubmission
H.C. Wainwright analyst Andrew Fein says that as DBV Technologie (DBVT) moves forward towards an anticipated Biologics License Application resubmission for Viaskin Peanut in Q3, he continues to be supportive of the overall value, safety, and efficacy of the Viaskin Peanut program. Following organizational updates, a "straightforward BLA resubmission could refresh investors' confidence in management, while addressing the regulatory overhang," Fein tells investors in a research note. He reiterates a Buy rating on DBV shares with a $25 price target. His confidence in the Viaskin Peanut program has been based on "exceptional safety and sufficient efficacy to manage the risk of accidental exposure." The analyst believes these properties differentiate Viaskin Peanut from the peanut oral immunotherapy being developed by Aimmune (AIMT).
08/09/19
RBCM
08/09/19
NO CHANGE
Target $50
RBCM
Outperform
Aimmune price target lowered to $50 from $58 at RBC Capital
RBC Capital analyst Kennen MacKay lowered his price target on Aimmune to $50 after its Q2 earnings miss, also reducing his launch expectations for AR101 based on the analysis of the "recent comparable drug launches into indications with a similar unmet need." The analyst still keeps his Outperform rating on the stock and sees AR101 as well positioned to "disrupt and build the peanut allergy desensitization market".
09/09/19
BARD
09/09/19
NO CHANGE
Target $64
BARD
Outperform
Aimmune added as a Fresh Pick, AdCom a binary event, says Baird
Baird analyst Brian Skorney Added Aimmune as a Fresh Pick ahead of Friday's AdCom event. The analyst said it will be mid-week briefing documents followed by Friday's meeting which he expects to be a binary event. He believes it should be a positive catalyst which could yield a 20-30% upside from its current price and he noted AR101 has shown robust efficacy in increasing the amount of peanut protein tolerated by patients during it PALISADE trial. Skorney reiterated his Outperform rating and $64 price target on Aimmune shares.
DBVT DBV Technologies
$9.72

0.75 (8.36%)

06/17/19
GSCO
06/17/19
INITIATION
Target $14
GSCO
Buy
DBV Technologies initiated with a Buy at Goldman Sachs
Goldman Sachs analyst Graig Suvannavejh started DBV Technologies (DBVT) with a Buy rating and $14 price target. DBVT is a late-stage specialty biotech company, with a proprietary technology platform that could be used to treat a range of food allergies, Suvannavejh tells investors in a research note. The analyst sees 66% upside from current share levels given the potential catalysts over the next 18 months, which include the Biologics License Applications re-filing in Q3 and FDA acceptance in Q4, a potential panel hearing in mid-2020, and likely final U.S. approval by the end of 2020. Suvannavejh sees an 85% probability of success for DBV's Viaskin Peanut and views the treatment as a more compelling option versus Aimmune's (AIMT) AR101 on overall safety and product presentation profiles.
06/17/19
06/17/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. DBV Technologies (DBVT) initiated with a Buy at Goldman Sachs. 2. Amicus (FOLD) initiated with a Buy at H.C. Wainwright. 3. Viper Energy (VNOM) initiated with a Buy at SunTrust. 4. GNC Holdings (GNC) initiated with a Hold at Jefferies. 5. Eventbrite (EB) initiated with an Outperform at William Blair. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
07/12/19
WEDB
07/12/19
NO CHANGE
Target $79
WEDB
Outperform
Aimmune selloff on ICER report overdone, says Wedbush
Wedbush analyst Liana Moussatos views the selloff yesterday in shares of Aimmune Therapeutics as overdone. The Institute for Clinical and Economic Review on Wednesday released a final report on emerging desensitization treatments for peanut allergy and compared the clinical effectiveness and value of Aimmune's AR101, DBV Technologies' (DBVT) Viaskin and non-commercialized oral immunotherapy for treatment of peanut allergy, Moussatos tells investors in a research note. However, the ICER report excluded long-term desensitization and patient quality-of-life results for AR101 and hence failed to recognize the full value of AR101 immunotherapy for peanut allergy, says the analyst. She sees an "excellent entry point" into Aimmune shares following yesterday's selloff and reiterates an Outperform rating on the name wih a $79 price target.

TODAY'S FREE FLY STORIES

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CMG

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CBRL

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REAL

RealReal

$17.00

0.21 (1.25%)

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CVS

CVS Health

$64.28

0.65 (1.02%)

, WAB

Wabtec

$74.01

0.26 (0.35%)

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WAB

Wabtec

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ABC

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CAH

Cardinal Health

$47.89

-0.14 (-0.29%)

MCK

McKesson

$146.83

1.06 (0.73%)

MYL

Mylan

$21.01

0.03 (0.14%)

AMRX

Amneal Pharmaceuticals

$3.34

0.21 (6.71%)

ABT

Abbott

$83.56

0.35 (0.42%)

MNK

Mallinckrodt

$2.46

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ENDP

Endo

$3.48

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TEVA

Teva

$7.44

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JNJ

Johnson & Johnson

$131.73

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DDAIF

Daimler AG

$0.00

(0.00%)

, FCAU

Fiat Chrysler

$13.52

-0.11 (-0.81%)

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Daimler AG

$0.00

(0.00%)

FCAU

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$13.52

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F

Ford

$9.16

0.06 (0.66%)

GM

General Motors

$37.37

-0.41 (-1.09%)

HMC

Honda

$26.68

0.03 (0.11%)

NSANY

Nissan

$0.00

(0.00%)

TSLA

Tesla

$240.62

-5.89 (-2.39%)

TM

Toyota

$136.72

0.12 (0.09%)

VWAGY

Volkswagen

$0.00

(0.00%)

FB

Facebook

$189.88

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AGU

Agrium

$0.00

(0.00%)

ANDE

Andersons

$26.28

-0.56 (-2.09%)

ADM

Archer Daniels

$40.94

0.05 (0.12%)

BG

Bunge

$55.91

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CF

CF Industries

$49.28

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CMP

Compass Minerals

$56.29

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IPI

Intrepid Potash

$3.43

0.01 (0.29%)

POT

Potash

$0.00

(0.00%)

SYT

Syngenta

$0.00

(0.00%)

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UPS

UPS

$120.71

1.61 (1.35%)

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DIS

Disney

$132.18

-1.14 (-0.86%)

, T

AT&T

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DIS

Disney

$132.18

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AT&T

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BA

Boeing

$379.33

-5.28 (-1.37%)

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MCF

Contango Oil & Gas

$1.71

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GLD

SPDR Gold Shares

$142.97

1.68 (1.19%)

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VXRT

Vaxart

$0.58

-0.0307 (-5.03%)

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AAPL

Apple

$217.69

-3.22 (-1.46%)

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IIVI

II-VI

$39.05

-0.5 (-1.26%)

, CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

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II-VI to enter S&P 400; Callon Petroleum, PriceSmart to enter S&P SmallCap600 »

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IIVI

II-VI

$39.05

-0.5 (-1.26%)

CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

FNSR

Finisar

$24.31

1.25 (5.42%)

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NVR

NVR

$3,632.55

-30.45 (-0.83%)

, JEF

Jefferies Financial Group

$19.47

-0.19 (-0.97%)

17:26
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NVR to replace Jefferies Financial Group in the S&P 500 at open on September 26 »

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NVR

NVR

$3,632.55

-30.45 (-0.83%)

JEF

Jefferies Financial Group

$19.47

-0.19 (-0.97%)

SPB

Spectrum Brands

$49.66

-1.395 (-2.73%)

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NOC

Northrop Grumman

$368.25

-7.45 (-1.98%)

17:24
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Northrop Grumman subsidiary awarded $1.12B Missile Defense Agency contract »

Orbital Sciences, or OSC,…

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PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

, FNSR

Finisar

$24.31

1.25 (5.42%)

17:23
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PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

FNSR

Finisar

$24.31

1.25 (5.42%)

03/08/13
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IIVI

II-VI

$39.05

-0.5 (-1.26%)

, CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

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IIVI

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$39.05

-0.5 (-1.26%)

CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

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NVR

NVR

$3,632.55

-30.45 (-0.83%)

17:20
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Hot Stocks
Breaking Hot Stocks news story on NVR »

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NHYDY

Norsk Hydro

$0.00

(0.00%)

17:12
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Norsk Hydro discloses federal court in Brazil lifts embargo on Alunortes »

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RESN

Resonant

$3.05

0.02 (0.66%)

17:03
09/20/19
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17:03
Conference/Events
Resonant participates in a conference call with Loop Capital »

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NINE

Nine Energy Services

$6.73

-0.33 (-4.67%)

17:02
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Syndicate
Breaking Syndicate news story on Nine Energy Services »

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ATOM

Atomera

$3.70

0.17 (4.82%)

17:00
09/20/19
09/20
17:00
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Conference/Events
Atomera participates in a conference call with Loop Capital »

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MPWR

Monolithic Power

$154.21

-2 (-1.28%)

16:50
09/20/19
09/20
16:50
09/20/19
16:50
Conference/Events
Monolithic Power participates in a conference call with Loop Capital »

Semiconductor Analysts…

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